Early Intervention Following Sexual Assault

NCT ID: NCT04582695

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2026-01-31

Brief Summary

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Detailed Description

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up. Next, a pilot randomized controlled trial will be conducted among 54 recent sexual assault victims to evaluate feasibility and preliminary efficacy in reducing AUD severity and PTSD symptoms. Ecological momentary assessments (EMA) will be used to assess alcohol use, craving, and affect during the five-week treatment phase.

Conditions

Ptsd; Alcohol Use Disorder; Sexual Assault and Rape

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Written Exposure Therapy

Group Type: ACTIVE_COMPARATOR

Written Exposure Therapy

Intervention Type: BEHAVIORAL

Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Group Type: EXPERIMENTAL

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Intervention Type: BEHAVIORAL

Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).

Interventions

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).

Intervention Type: BEHAVIORAL

Written Exposure Therapy

Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female; any race or ethnicity; age 18 to 65 years old.
• Sexual assault that occurred within the past 12 months.
• Subjects must be able to comprehend English.
• A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen.

Exclusion Criteria

• Must consent to complete all treatment and follow-up visits.

• Lack of any memory of the sexual assault
• Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.
• Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
• Individuals considered an immediate suicide risk, with current suicidal ideation and intent.
• Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment.
• Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.
• Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Christine Hahn

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

Reference Type: DERIVED

PMID: 37795783 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23AA028055

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00099114

Identifier Type: -

Identifier Source: org_study_id